Establishment of the Leicester Clinical Trials Unit (LCTU) at the University of Leicester
LCTU functions as a partnership between the University of Leicester and the University Hospitals of Leicester NHS Trust for the delivery of clinical trials. We provide an infrastructure to bring together the expertise of academic clinicians and other health service researchers in Leicester, the East Midlands and beyond.
LCTU was set up in 2009 by the University of Leicester, with core funding provided through the College of Life Sciences. Following a rigorous registration process we achieved 'full registration' status in 2013 and were re-accredited in 2017.
LCTU is a UK Clinical Research Collaboration (UKCRC) registered clinical trial unit working with Investigators from across a range of therapeutic areas.
We work in collaboration with researchers, investigators and clinicians to design and conduct high quality multi-site randomised controlled trials (RCTs). We have expertise in the following: trial methodology and design; site set-up and central trial management; IT and data management; trial statistics and conducting of final data analysis.
Establishing and maintaining on-going relationships with you, our investigators, is a priority area for us. We invest a significant level of commitment to each funding application with the common goal of succeeding in high quality funding applications, the delivery of first class research, and the development of a track record of success.
All CTUs are managed under a strict UKCRC operating framework and are performance monitored on a yearly basis. The trials we support must, therefore, contribute to the on-going registration process we are mandated to undergo in order to retain our UKCRC registration. This is achieved by engaging in a true collaboration between us and you, the investigator, rather than simply providing stand-alone services.
Whilst one of our key performance areas is the support of NIHR funded multi-site RCTs with central CTU oversight (as demonstrated below with an extract from the UKCRC website), we are committed to assessing each collaboration request on its merits, whilst considering our current workload commitments.
We are an academic unit, providing expertise and support for the management of multi-centre RCTs along with other complex studies. These we deliver to the standards required by regulatory authorities such as the Medicines and Healthcare products Regulatory Agency (MHRA), as well as providing support in the form of specified trial-related services such as building high quality databases. Observational or cohort studies that require significant levels of data management also benefit from LCTU support.
We aim to facilitate the conduct of high quality clinical research and ensure the generation of reliable evidence for the management of a wide range of diseases.
As an academic research unit, we are particularly interested in supporting studies that reduce the uncertainties facing doctors and patients in daily clinical practice. These studies are typically funded from external sources, such as the National Institute for Health Research (NIHR) funding schemes and medical charities.
We welcome and encourage you to make contact with us early in the development of your application or protocol. The steps to do this are outlined on the Collaborate with us page.
We support investigators by providing access to our core competencies of
- Trial design
- Multi-site trial management
- Database provision and data management
The services available from the LCTU include contribution to funding applications, trial design, sample size calculations, protocol development, ethics committee and regulatory submissions, database build and data management, randomisation, trial management, data entry, analysis, interpretation and statistical reporting.
Clinical Trials Units and The Cochrane Collaboration
A key part of the infrastructure for clinical trials in the UK is provided by more than 50 clinical trials units across the country, of which Leicester is one. This podcast, featuring Professor Julia Brown, Director of the Clinical Trial Units Network, talks about the value and contribution of Clinical Trials Units for The Cochrane Collaboration and their contribution to ensuring that clinical trials improve lives.